Growth Hormone Deficiency Clinical Trial
Official title:
Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency
The purpose of the proposed study is to investigate the effects of rhGH treatment on
glucose, protein and fat metabolism in GHD children. Specifically, the investigators will
measure the rates of glucose production, gluconeogenesis, glycogenolysis, insulin
sensitivity and glucagon response before and after treatment with rhGH. In addition, the
investigators will study changes in protein and fat metabolism pre and post rhGH therapy in
children with GHD. The findings in the GHD children will be compared to those of a control
group of age and sex matched healthy children.
Hypotheses: H1- The fraction of glucose derived from gluconeogenesis is decreased and that
from glycogenolysis is increased in the post-absorptive state in untreated GHD children when
compared to healthy children. H2- Treatment with rhGH will not change the overall glucose
turnover but will normalize the abnormal partitioning of gluconeogenesis and glycogenolysis
in GHD children. H3- GH replacement will reduce urea production and increase estimates of
protein synthesis, thus optimizing the availability of amino acids for growth. H4- Untreated
children with GHD after an overnight fast will have an increased glucagon challenge response
that will decrease after 8 weeks of treatment with rhGH.
Specific Aims: In healthy and newly diagnosed GHD children the investigators will: 1.
Measure the Glucose Production Rate (GPR) 2. Determine the fraction of glucose derived from
gluconeogenesis and glycogenolysis 3. Estimate insulin sensitivity 4. Measure proteolysis
and protein oxidation 5. Determine glucagon challenge response after an overnight fast. The
above-mentioned parameters will be re-evaluated in the children with GHD after 8 weeks of
rhGH therapy.
Children with growth hormone deficiency (GHD) have increased insulin sensitivity and may present with hypoglycemia during infancy. Treatment with recombinant human growth hormone (rhGH) reduces the risk for hypoglycemia and decreases insulin sensitivity. The investigators hypothesize, that GHD causes a decrease in the fraction of glucose derived form gluconeogenesis and conversely glycogenolysis and insulin sensitivity will be increased, when GHD children are compared to healthy controls. The investigators anticipate that total glucose production will be unaffected by rhGH therapy. Therefore, the GDH subjects treated with rhGH for 8 weeks will have an increase in the fraction of glucose derived form gluconeogenesis and a decrease in that form glycogenolysis and decreased insulin sensitivity. To test this hypothesis, 10 healthy and 10 GHD children will be studied using the stable isotope [U-13C] glucose and Mass Isotopes Distribution Analysis (MIDA). The investigators will be specifically measuring the rate of glucose production, gluconeogenesis, glycogenolysis, insulin sensitivity and glucagon response after an overnight fast. In addition, the investigators will measure changes in protein oxidation, proteolysis and fat metabolism using the stable isotopes [15N2] urea, [1-13C] leucine and concentrations of free fatty acids and b-hydroxybutyrate. The GHD group will be studied at the time of diagnosis and after 8 weeks of rhGH. ;
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